Dual blade lancing test strip

ABSTRACT

An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

BACKGROUND OF THE INVENTION

The present invention generally relates to bodily fluid sampling devicesand more specifically, but not exclusively, concerns an integratedlancing test strip.

General Fluid Testing

The acquisition and testing of bodily fluids is useful for manypurposes, and continues to grow in importance for use in medicaldiagnosis and treatment, and in other diverse applications. In themedical field, it is desirable for lay operators to perform testsroutinely, quickly and reproducibly outside of a laboratory setting,with rapid results and a readout of the resulting test information.Testing can be performed on various bodily fluids, and for certainapplications is particularly related to the testing of blood and/orinterstitial fluid. Such fluids can be tested for a variety ofcharacteristics of the fluid, or analytes contained in the fluid, inorder to identify a medical condition, determine therapeutic responses,assess the progress of treatment, and the like.

General Test Steps

The testing of bodily fluids basically involves the steps of obtainingthe fluid sample, transferring the sample to a test device, conducting atest on the fluid sample, and displaying the results. These steps aregenerally performed by a plurality of separate instruments or devices.

Acquiring—Vascular

One method of acquiring the fluid sample involves inserting a hollowneedle or syringe into a vein or artery in order to withdraw a bloodsample. However, such direct vascular blood sampling can have severallimitations, including pain, infection, and hematoma and other bleedingcomplications. In addition, direct vascular blood sampling is notsuitable for repeating on a routine basis, can be extremely difficultand is not advised for patients to perform on themselves.

Acquiring—Incising

The other common technique for collecting a bodily fluid sample is toform an incision in the skin to bring the fluid to the skin surface. Alancet, knife or other cutting instrument is used to form the incisionin the skin. The resulting blood or interstitial fluid specimen is thencollected in a small tube or other container, or is placed directly incontact with a test strip. The fingertip is frequently used as the fluidsource because it is highly vascularized and therefore produces a goodquantity of blood. However, the fingertip also has a large concentrationof nerve endings, and lancing the fingertip can therefore be painful.Alternate sampling sites, such as the palm of the hand, forearm, earlobeand the like, may be useful for sampling, and are less painful. However,they also produce lesser amounts of blood. These alternate sitestherefore are generally appropriate for use only for test systemsrequiring relatively small amounts of fluid, or if steps are taken tofacilitate the expression of the bodily fluid from the incision site.

Various methods and systems for incising the skin are known in the art.Exemplary lancing devices are shown, for example, in U.S. Pat. No. Re35,803, issued to Lange, et al. on May 19, 1998.; U.S. Pat. No.4,924,879, issued to O'Brien on May 15, 1990; U.S. Pat. No. 5,879,311,issued to Duchon et al. on Feb. 16, 1999; U.S. Pat. No. 5,857,983,issued to Douglas on Jan. 12, 1999; U.S. Pat. No. 6,183,489, issued toDouglas et al. on Feb. 6, 2001; U.S. Pat. No. 6,332,871, issued toDouglas et al. on Dec. 25, 2001; and U.S. Pat. No. 5,964,718, issued toDuchon et al. on Oct. 12, 1999. A representative commercial lancingdevice is the Accu-Chek Softclix lancet.

Expressing

Patients are frequently advised to urge fluid to the incision site, suchas by applying pressure to the area surrounding the incision to milk orpump the fluid from the incision. Mechanical devices are also known tofacilitate the expression of bodily fluid from an incision. Such devicesare shown, for example, in U.S. Pat. No. 5,879,311, issued to Duchon etal. on Feb. 16, 1999, U.S. Pat. No. 5,857,983, issued to Douglas on Jan.12, 1999; U.S. Pat. No. 6,183,489, issued to Douglas et al. on Feb. 6,2001; U.S. Pat. No. 5,951,492, issued to Douglas et al. on Sep. 14,1999; U.S. Pat. No. 5,951,493, issued to Douglas et al. on Sep. 14,1999; U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct. 12, 1999;and U.S. Pat. No. 6,086,545, issued to Roe et al. on Jul. 11, 2000. Arepresentative commercial product that promotes the expression of bodilyfluid from an incision is the Amira AtLast blood glucose system.

Sampling

The acquisition of the produced bodily fluid, hereafter referred to asthe “sampling” of the fluid, can take various forms. Once the fluidspecimen comes to the skin surface at the incision, a sampling device isplaced into contact with the fluid. Such devices may include, forexample, systems in which a tube or test strip is either locatedadjacent the incision site prior to forming the incision, or is moved tothe incision site shortly after the incision has been formed. A samplingtube may acquire the fluid by suction or by capillary action. Suchsampling systems may include, for example, the systems shown in U.S.Pat. No. 6,048,352, issued to Douglas et al. on Apr. 11, 2000; U.S. Pat.No. 6,099,484, issued to Douglas et al. on Aug. 8, 2000; and U.S. Pat.No. 6,332,871, issued to Douglas et al. on Dec. 25, 2001. Examples ofcommercial sampling devices include the Roche Compact, Amira AtLast,Glucometer Elite and Therasense FreeStyle test strips.

Testing General

The bodily fluid sample may be analyzed for a variety of properties orcomponents, as is well known in the art. For example, such analysis maybe directed to hematocrit, blood glucose, coagulation, lead, iron, etc.Testing systems include such means as optical (e.g., reflectance,absorption, fluorescence, Raman, etc.), electrochemical, and magneticmeans for analyzing the sampled fluid. Examples of such test systemsinclude those in U.S. Pat. No. 5,824,491, issued to Priest et al. onOct. 20, 1998; U.S. Pat. No. 5,962,215, issued to Douglas et al. on Oct.5, 1999; and U.S. Pat. No. 5,776,719, issued to Douglas et al. on Jul.7, 1998.

Typically, a test system takes advantage of a reaction between thebodily fluid to be tested and a reagent present in the test system. Forexample, an optical test strip will generally rely upon a color change,i.e., a change in the wavelength absorbed or reflected by dye formed bythe reagent system used. See, e.g., U.S. Pat. Nos. 3,802,842; 4,061,468;and 4,490,465.

Blood Glucose

A common medical test is the measurement of blood glucose level. Theglucose level can be determined directly by analysis of the blood, orindirectly by analysis of other fluids such as interstitial fluid.Diabetics are generally instructed to measure their blood glucose levelseveral times a day, depending on the nature and severity of theirdiabetes. Based upon the observed pattern in the measured glucoselevels, the patient and physician determine the appropriate level ofinsulin to be administered, also taking into account such issues asdiet, exercise and other factors.

In testing for the presence of an analyte such as glucose in a bodilyfluid, test systems are commonly used which take advantage of anoxidation/reduction reaction which occurs using an oxidase/peroxidasedetection chemistry. The test reagent is exposed to a sample of thebodily fluid for a suitable period of time, and there is a color changeif the analyte (glucose) is present. Typically, the intensity of thischange is proportional to the concentration of analyte in the sample.The color of the reagent is then compared to a known standard whichenables one to determine the amount of analyte present in the sample.This determination can be made, for example, by a visual check or by aninstrument, such as a reflectance spectrophotometer at a selectedwavelength, or a blood glucose meter. Electrochemical and other systemsare also well known for testing bodily fluids for properties onconstituents.

Testing Difficulties

Performing the above-discussed steps can be difficult for patients,especially for patients with limited hand dexterity, such as theelderly. In a typical procedure, the patient first creates an incisionin the skin by lancing the skin with a lancet. In order to ensure that asufficient number of capillaries are cut for supplying an adequatebodily fluid sample, the incision has to usually be deep, which can berather painful for the patient. Often, the incision cite still does notprovide an adequate amount bodily fluid for the sample, and the patientthen must resort to expressing the fluid for the cite. If duringexpression of the fluid the patient is not careful, smearing of thefluid may occur, which may result in rendering the sample useless. Oncea sufficient amount of fluid collects as a droplet on the skin, thepatient has to position a test strip over the cite such that the teststrip contacts and absorbs a sufficient amount of the droplet fortesting. Usually the droplet of fluid is quite small, and patients,especially ones with hand motor control problems, may experience greatdifficulty in positioning the test strip so as to collect a sample fromthe droplet. As should be appreciated, patients can become frustrated bythis procedure, and consequently, they may perform the test less oftenor may even quit testing altogether.

Thus, needs remain for further contributions in this area of technology.

SUMMARY OF THE INVENTION

One form of the present invention generally concerns an integratedlancing test strip device for collecting and analyzing bodily fluid fromone or more incisions in the skin. The device includes at least a pairof blade members that define an internal capillary. The blade membershave a pair of lancing tips configured to lance the incisions in theskin and positioned to draw bodily fluid from the incisions into theinternal capillary via capillary action. Test media is positioned alongthe internal capillary to analyze the bodily fluid.

Another form concerns an integrated bodily fluid sampling device. Thedevice includes a first blade member that has a first lancing tipconfigured to lance the skin and a second blade member that has a secondlancing tip configured to lance the skin. A pair of spacer membersattach the first blade member to the second blade member. The blademembers and the spacer members define a cavity to collect bodily fluid.A means for testing the bodily fluid is positioned along the cavity.

A further form concerns a method that includes providing a lancingdevice. The lancing device includes a pair of blade members that definean internal capillary and a test strip positioned along the internalcapillary. One or more incisions are lanced in skin with the blademembers. Bodily fluid from the incisions are drawn onto the test stripvia capillary action through the internal capillary.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an integrated lancet device according toone embodiment of the present invention.

FIG. 2 is a perspective view of the FIG. 1 lancet with the one bladeelement removed.

FIG. 3 is a side view of the FIG. 1 lancet drawing fluid from anincision.

FIG. 4 is a perspective view of an integrated lancet device according toanother embodiment of the present invention.

FIG. 5 is a side view of the FIG. 4 lancet drawing fluid from anincision.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

The present invention generally concerns an integrated skin lancingdevice that reduces the pain as well as the number of steps involved informing, collecting and testing a bodily fluid sample from an incision.The device includes a pair of generally flat blade members with eachhaving a cutting tip configured to cut an incision into the skin. In oneembodiment, the cutting tips extend in generally parallel relationshipto one another, and in another embodiment, the tips are angled tocontact one another in order to improve their overall strength. Incomparison to single blade designs, the two blades of the presentinvention can cut into the skin at a shallower depth, while stillensuring a sufficient number of capillaries are cut so as to create anadequate fluid supply. By cutting an incision with a shallower depth,less pain may be experienced during lancing. Moreover, the blades can bepositioned sufficiently close together such that an incision created byeach blade is only sensed by the patient as a single incision. The twoblade members are joined together through a pair of spacer or adhesivebeads that define an internal capillary channel between the blademembers. In one form of the present invention, the capillary channel isempty such that fluid is drawn via capillary action through thecapillary channel. In another form of the present invention, thecapillary channel is filled with a wicking material that transports thebodily fluid sample. Along the capillary channel, the lancet includes atest strip that is configured to test analyte levels in the sample.

During use, the lancet device is extended to lance a pair of incisionsin the skin. After the incisions are formed, the cutting tips arewithdrawn from the incisions to a position proximal the incisions. Asthe bodily fluid from the incisions collects on the skin, the fluid isdrawn into the gap between the two blade tips and into the internalcapillary via capillary action. Next, the blood travels through theinternal capillary and is deposited on the test strip for testing. Asshould be appreciated, the integrated, dual blade design of the presentinvention reduces the pain involved and the number of steps associatedwith testing.

A dual blade, integrated lancing test strip or device 20 according toone embodiment of the present invention is illustrated in FIGS. 1-3. Asshown in FIG. 1, the lancing device 20 includes first 22 and second 24blade members that extend in a parallel relationship. In the illustratedembodiment, blade members 22 and 24 have a generally flat shape suchthat device 20 is in the form of a flat lancet. By being generally flat,blade members 22 and 24 can be easily formed from sheets of material,such as metal, and these sheets can be sandwiched together to form massquantities of the lancing devices 20 at the same time. Moreover, theflat design allows multiple lancing devices 20 to be connected togetherso as to be used in a cartridge, such as the drum in an ACCU-CHEKCOMPACT™ brand meter (Roche Diagnostics Corp., Indianapolis, Ind.). Thelancing device 20 can also be a stand-alone lancet that is dispensed andused individually. In one embodiment, blade members 22 and 24 are madeof metal, in particular stainless steel, but it should be appreciatedthat blade members 22 and 24 can be made of other materials, such asplastic and/or ceramics.

Spacer members 26 and 28 join the first 22 and second 24 blade memberstogether so as to define an internal capillary 30. Spacer members 26 and28 in one embodiment are beads of adhesive, and in another embodimentare strips of adhesive tape. As should be appreciated, spacer members 26and 28 can be made of other materials. The internal capillary 30 formedbetween the blade members 22, 24 is sized to draw fluid via capillaryaction. For instance, blade members 22 and 24 in one form of the presentinvention are spaced apart from one another between two-thousandths ofan inch (0.002″) and ten-thousandths of an inch (0.010″) to form theinternal capillary 30 of that size. In another form, blade members 22and 24 are preferably spaced apart between about two-thousandths of aninch (0.002″) to three-thousandths of an inch (0.003″) so as to improvethe flow rate in the internal capillary 30.

Each blade 22, 24 has a lancing tip 32 at one end that define acapillary gap 34, which opens into one end of the internal capillary 30.As depicted in FIG. 2, the other end of the internal capillary 30 isenclosed by a vent block 36. The vent block 36 in one embodiment is madeof plastic, but it should be appreciated that vent block 36 can be madefrom other materials. By way of nonlimiting examples, the vent block 36can be made from metal, plastic, an adhesive bead, and/or adhesive tape,to name a few.

The lancing tips 32 are shaped to cut an incision in the skin. In theembodiment illustrated in FIG. 1, the lancing tips 32 of the first 22and second 24 blade members extend in a parallel relationship withrespect to one another and have a general triangular shape. The lancingtips 32 in other embodiments, however, can have a different shape. Aswill be discussed in further detail below, by extending parallel to oneanother, the tips 32 are able to cut a pair of incisions in the skin. Itshould be understood that device 20 in other embodiments canincorporated more than two lancing tips 32. By having two (or more)lancing tips 32, a more shallow penetration depth may be used to collectthe same amount of fluid, thereby reducing the associated pain withlancing.

It has also been discovered that the distance between nerve endingsvaries depending on the location on the body. For instance, nerveendings are highly concentrated in the fingertips and are lessconcentrated along the forearm. The lancing tips 32 in one embodimentare spaced apart a small distance such that the nerves endings in thepatient are unable to differentiate between the two incisions formed bythe lancing tips 32 so that the patient only experiences the sensationof a single incision. In other embodiments, the spacing between thelancing tips 32 can be sized depending on the location where theincision is desired to be formed. In one particular embodiment, the tips32 are spaced apart between two-thousandths of an inch (0.002″) tothree-thousandths of an inch (0.003″).

Referring to FIG. 1, the vent block 36 defines a registration opening37, and a test strip or media 38 is positioned along the internalcapillary 30 in order to receive fluid drawn by the internal capillary30. The test strip 38 is operable to test analyte levels in bodilyfluid. The test strip 38 can analyze fluid through such means as optical(e.g., reflectance, absorption, fluorescence, Raman, etc.),electrochemical, and magnetic analysis, to name a few. In oneembodiment, the test strip 38 analyzes the fluid optically. Among itsmany functions, the registration opening 37 is used to align device 20in a testing system such that the test strip 38 is properly positionedfor analysis. As shown, a test strip opening 40 is defined between thevent block 36 and the first blade member 22. The test strip 38 in FIG. 1is attached to the spacer members 26, 28 in the test strip opening 40.Generally, test strips can be sensitive to environmental factors thatexist during sterilization. So as to avoid the need to recalibrate thetest strip 38 after sterilization, the test strip 38 in one embodimentis attached after sterilization of the blade members 22, 24. The teststrip 38 has a width that is slightly smaller than the width of the teststrip opening 40 such that a vent opening 42 is formed between the teststrip 38 and the vent block 36. The vent opening 42 allows air to bevented from the internal capillary 30, thereby improving the flow of thebodily fluid within the capillary 30. By integrating the testing as wellas the collection of the bodily fluid into the same lancing device 20,less fluid is required in order to provide an adequate sample to thetest strip 38.

Referring now to FIG. 3, the lancing device 20 is used to form a pair ofincisions 44 in skin 46. After the incisions 44 are formed, the tips 32are withdrawn from the incisions 44 and positioned proximal to the skin46 such that bodily fluid 48 is able to freely flow from the incisions44 and form a drop on the skin 46. The lancing tips 32 can be withdrawnand positioned proximal the drop of fluid 48 either manually by thepatient or automatically through the use of a retraction mechanism, suchas a spring. As the drop of fluid 48 forms on the skin 46, the fluid 48is wicked via capillary action into the capillary gap 30. From gap 30,the sample of fluid 48 then travels through the internal capillary 30and is deposited on the test strip 38. The device 20 remains in positionfor collecting fluid until a sufficient amount has been collected on thetest strip 38. Once a sufficient amount of bodily fluid 48 has beencollected, device 20 can be removed from the vicinity of the skin 46.

An integrated lancing test strip or device 50, according to anotherembodiment of the present invention, will now be described withreference to FIGS. 4 and 5. Device 50 has many components similar to theones described above, with the notable exceptions discussed below.Device 50 includes vent block 36 with registration opening 37, teststrip 38, and vent opening 42, which are shown in FIG. 1. As depicted inFIG. 4, device 50 further includes first 22 a and second 24 a blademembers that are attached through the spacer members 26 and 28. As inthe previously discussed embodiment, device 50 in FIG. 4 is in the formof a generally flat lancet. The spacer members 26, 28 along with theblade members 22 a, 24 a define an internal capillary 30 a. In theillustrated embodiment, wicking material 52 is received in the internalcapillary for drawing fluid to the test strip 38. The wicking materialcan be selected from various materials including, but not limited to,Pall Accuwick and Whatman 41, which provide a high enough capillaryaction to wick the fluid onto the test strip.

Similar to the embodiment described above, the blade members 22 a and 24a have lancing tips 32 a extending therefrom. In comparison to theprevious embodiment, lancing tips 32 a in the embodiment illustrated inFIGS. 4 and 5 are angled towards one another. As shown in theillustrated embodiment, the outermost ends of the lancing tips 32 acontact one another. By angling towards one another, tips 32 a are ableto support one another, thereby increasing the overall strength of thelancing tips 32 a. This construction can allow the blade members 22 a,24 a to be formed from thinner material, while still having adequatestrength for forming an incision. In another embodiment, tips 32 a areangled towards one another, but their outermost ends are slightly spacedapart such that tips 32 a do not contact one another. With thisembodiment, the lancing tips 32 a can support one another by contactingduring deflection of the lancing tips 32 a. Referring again to theembodiment illustrated in FIG. 5, the tips 32 a of device 50 define acapillary gap 34 a in which bodily fluid is drawn via capillary action.In the illustrated embodiment, the wicking material 52 does not extendinto capillary gap 34. However, it is contemplated that in otherembodiments the wicking material 52 fills gap 34 a.

As shown in FIG. 5, device 50 samples fluid in a manner very similar tothe embodiment described above. However, when tips 32 a in device 50contact each other, only a single incision 44 is formed in the skin. Itshould be appreciated that when the lancing tips 32 a are slightlyspaced apart, two incisions 44 can be formed in the skin 46. As in theembodiment before, tips 32 a are positioned proximal to the incision 44after lancing so as to be able to collect bodily fluid 48 from theincision 44. As shown, the bodily fluid 48 is drawn into gap 34 a andthen into the wicking material 52 in internal capillary 30 a. Thewicking material 52 deposits the bodily fluid 48 onto the test strip 38.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

1. An integrated lancing test strip device for collecting and analyzingbodily fluid from one or more incisions in skin, comprising: at least apair of blade members defining an internal capillary; the blade membershaving at least a pair of lancing tips that are configured to lance theone or more incisions in the skin and positioned to draw bodily fluidfrom the one or more incisions into the internal capillary via capillaryaction; and test media positioned along the internal capillary toanalyze the bodily fluid.
 2. The device of claim 1, wherein the lancingtips are oriented parallel to one another.
 3. The device of claim 1,wherein the lancing tips are angled towards one another.
 4. The deviceof claim 3, wherein the lancing tips touch one another.
 5. The device ofclaim 1, further comprising at least a pair of spacer members attachedbetween the blade members.
 6. The device of claim 1, further comprising:a vent block provided at one end of the capillary opposite the lancingtips; and wherein the test media and the vent block define a ventopening for exhausting gas from the internal capillary.
 7. The device ofclaim 6, wherein said vent block defines a registration opening foraligning the device.
 8. The device of claim 1, further comprisingwicking material received in the internal capillary.
 9. The device ofclaim 1, wherein the test media includes a reagent test strip.
 10. Thedevice of claim 1, wherein the lancing tips have a triangularcross-sectional shape.
 11. The device of claim 1, wherein the blademembers are flat.
 12. The device of claim 11, further comprising: atleast a pair of spacer members attached between the blade members; avent block provided at one end of the capillary opposite the lancingtips, said vent block defining a registration opening for aligning thedevice, wherein the vent block defines a vent opening for exhausting gasfrom the internal capillary; and wherein the lancing tips have atriangular cross-sectional shape.
 13. The device of claim 12, whereinthe lancing tips are oriented parallel to one another.
 14. The device ofclaim 12, wherein the lancing tips are angled towards one another. 15.The device of claim 14, further comprising wicking material received inthe internal capillary.
 16. An integrated bodily fluid sampling device,comprising: a first blade member having a first lancing tip configuredto lance skin; a second blade member having a second lancing tipconfigured to lance the skin; at least a pair of spacer membersattaching the first blade member to the second blade member, the blademembers and the spacer members defining a cavity to collect bodilyfluid; and means for testing the bodily fluid positioned along thecavity.
 17. The device of claim 16, wherein the means for testing thebodily fluid includes a reagent test strip adapted to indicate analytelevels in the bodily fluid.
 18. The device of claim 16, wherein thefirst and second lancing tips have a generally triangular crosssectional shape.
 19. The device of claim 16, wherein the first blademember is flat.
 20. The device of claim 19, wherein the second blademember is flat.
 21. The device of claim 16, wherein the lancing tipsextend parallel to one another.
 22. The device of claim 16, wherein thefirst and second lancing tips angle towards one another.
 23. The deviceof claim 22, wherein the first and second lancing tips contact oneanother.
 24. The device of claim 16, wherein the first and secondlancing tips define a capillary gap configured to draw the bodily fluidvia capillary action.
 25. The device of claim 16, further comprising avent member enclosing one end of the cavity opposite the first andsecond lancing tips.
 26. The device of claim 25, wherein the means fortesting the bodily fluid is positioned along the cavity between thefirst blade member and the vent member.
 27. The device of claim 26,wherein the means for testing the bodily fluid and the vent memberdefine a vent opening for exhausting gas from the cavity.
 28. The deviceof claim 25, wherein the vent member defines a registration opening. 29.The device of claim 16, wherein the cavity includes an internalcapillary sized to draw the bodily fluid via capillary action.
 30. Thedevice of claim 16, further comprising wicking material received in thecavity.
 31. The device of claim 16, wherein the first and second blademembers are metallic.
 32. The device of claim 16, wherein the spacermembers include adhesive beads.
 33. An apparatus, comprising: a samplingdevice defining a capillary channel for drawing body fluid, the samplingdevice including at least a pair of spacer members that define thecapillary channel; a vent member extending between the spacer members; atesting portion disposed along the capillary channel for analyzing thebody fluid, and a strip attached to the spacer members, the stripextending across the capillary channel, the strip being spaced away fromthe vent member to define a vent opening for venting the capillarychannel as the body fluid fills the capillary channel.
 34. The apparatusof claim 33, wherein: the testing portion includes a test strip; and thestrip disposed across the capillary channel includes the test strip. 35.The apparatus of claim 34, wherein: the vent member includes a ventblock; and the vent opening is defined between the test strip and thevent block.
 36. The apparatus of claim 33, wherein the sampling deviceincludes an integrated lancing test strip that includes a pair of blademembers defining the capillary channel.
 37. The apparatus of claim 33,wherein the vent opening has a slot shape.
 38. The apparatus of claim33, further comprising means for venting the capillary channel, whereinthe means for venting the capillary channel includes the vent opening.